Incidence of Conjunctivitis and Keratitis Among Individuals with Moderate-to-Severe Atopic Dermatitis Treated with Dupilumab in the United States: a Cohort Study in Routine Care Based on Healthcare Claims.

IF 3.5 3区 医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2025-03-13 DOI:10.1007/s13555-025-01367-5
Jessica M Franklin, Andrea F Marcus, Ihtisham Sultan, Ashley Howell, Sarah-Jo Sinnott, Jeannette Green, Stephen Ezzy, Robert Gately, Rachel E Sobel, Florence T Wang
{"title":"Incidence of Conjunctivitis and Keratitis Among Individuals with Moderate-to-Severe Atopic Dermatitis Treated with Dupilumab in the United States: a Cohort Study in Routine Care Based on Healthcare Claims.","authors":"Jessica M Franklin, Andrea F Marcus, Ihtisham Sultan, Ashley Howell, Sarah-Jo Sinnott, Jeannette Green, Stephen Ezzy, Robert Gately, Rachel E Sobel, Florence T Wang","doi":"10.1007/s13555-025-01367-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>In clinical trials of patients with atopic dermatitis (AD), conjunctivitis and keratitis occurred more frequently with dupilumab than placebo. Studies using real-world data have also shown a higher incidence with dupilumab but did not use validated algorithms to identify the population and outcomes. The objective of this study was to investigate the incidence of conjunctivitis and keratitis among patients with moderate-to-severe AD treated with dupilumab relative to dupilumab-naïve patients in a real-world setting using validated algorithms.</p><p><strong>Methods: </strong>A retrospective observational cohort study was conducted in an insurance claims database using validated algorithms for moderate-to-severe AD and ocular outcomes. Initiators of dupilumab were identified and propensity score (PS) matched with dupilumab-naïve patients with moderate-to-severe AD. Incidence rate ratios (IRRs) with 95% confidence intervals (CIs) for conjunctivitis and keratitis during follow-up were estimated using Poisson regression.</p><p><strong>Results: </strong>Among 13,790 patients in the moderate-to-severe AD study population, 2175 dupilumab initiators and 2189 dupilumab-naïve patients were included in the analysis. Dupilumab was associated with an increased risk of conjunctivitis (IRR = 1.86 [95% CI 1.51-2.30]) and keratitis (IRR = 4.06 [95% CI 1.70-9.68]) compared to patients with moderate-to-severe AD not receiving dupilumab. The cumulative 1-year risk of conjunctivitis was 15.8% and 8.4% in the dupilumab and dupilumab-naïve cohorts, respectively; the cumulative 1-year risk of keratitis was 1.3% and 0.2%, respectively.</p><p><strong>Conclusion: </strong>Study findings are consistent with safety data from clinical trials and existing literature. However, a few keratitis events were observed, and post hoc analyses suggested residual confounding might be present. The known benefit-risk profile for dupilumab remains unchanged.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01367-5","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Introduction: In clinical trials of patients with atopic dermatitis (AD), conjunctivitis and keratitis occurred more frequently with dupilumab than placebo. Studies using real-world data have also shown a higher incidence with dupilumab but did not use validated algorithms to identify the population and outcomes. The objective of this study was to investigate the incidence of conjunctivitis and keratitis among patients with moderate-to-severe AD treated with dupilumab relative to dupilumab-naïve patients in a real-world setting using validated algorithms.

Methods: A retrospective observational cohort study was conducted in an insurance claims database using validated algorithms for moderate-to-severe AD and ocular outcomes. Initiators of dupilumab were identified and propensity score (PS) matched with dupilumab-naïve patients with moderate-to-severe AD. Incidence rate ratios (IRRs) with 95% confidence intervals (CIs) for conjunctivitis and keratitis during follow-up were estimated using Poisson regression.

Results: Among 13,790 patients in the moderate-to-severe AD study population, 2175 dupilumab initiators and 2189 dupilumab-naïve patients were included in the analysis. Dupilumab was associated with an increased risk of conjunctivitis (IRR = 1.86 [95% CI 1.51-2.30]) and keratitis (IRR = 4.06 [95% CI 1.70-9.68]) compared to patients with moderate-to-severe AD not receiving dupilumab. The cumulative 1-year risk of conjunctivitis was 15.8% and 8.4% in the dupilumab and dupilumab-naïve cohorts, respectively; the cumulative 1-year risk of keratitis was 1.3% and 0.2%, respectively.

Conclusion: Study findings are consistent with safety data from clinical trials and existing literature. However, a few keratitis events were observed, and post hoc analyses suggested residual confounding might be present. The known benefit-risk profile for dupilumab remains unchanged.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
求助全文
约1分钟内获得全文 去求助
来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
期刊介绍: Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
期刊最新文献
Incidence of Conjunctivitis and Keratitis Among Individuals with Moderate-to-Severe Atopic Dermatitis Treated with Dupilumab in the United States: a Cohort Study in Routine Care Based on Healthcare Claims. High Systemic Disease Risk and Therapeutic Delays in Plaque Psoriasis: A Retrospective Analysis of Apremilast Use in the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR). Defining Predictive Factors for Permanent Chemotherapy-Induced Alopecia: Trichoscopy, Reflectance Confocal Microscopy and Histopathology Study on 77 Patients. Chronic Hand Eczema (CHE): A Narrative Review. Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1